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Aadi Bioscience
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17383 Sunset Blvd, Pacific Palisades, CA 90272, USA
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ABI-009 (Nab-sirolimus) is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).


Lead Product(s): Nab-sirolimus,Sotorasib,Adagrasib

Therapeutic Area: Oncology Product Name: ABI-009

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2022

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Under the terms of the collaboration agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study of Adagrasib (MRTX849), and jointly with Aadi, will oversee and share the cost of the study.


Lead Product(s): Adagrasib,Nab-sirolimus

Therapeutic Area: Oncology Product Name: MRTX849

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Mirati Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership October 12, 2022

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The company intends to use net proceeds from the financing to fund research and development of Nab-sirolimus and additional clinical opportunities with FYARRO and for working capital and general corporate purposes.


Lead Product(s): Nab-sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Avoro Capital

Deal Size: $72.5 million Upfront Cash: Undisclosed

Deal Type: Private Placement September 22, 2022

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Nab-sirolimus is an albumin-bound mTOR inhibitor approved by the U.S. Food and Drug Administration (FDA) as FYARRO™ for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.


Lead Product(s): Nab-sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2022

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Partners will collect and analyze clinical and molecular data to determine which patients may be eligible to participate in Aadi’s PRECISION 1 clinical trial for ABI-009. The goals are to increase patient match rate, reduce screen failure rate and increase speed of enrollment.


Lead Product(s): Nab-sirolimus

Therapeutic Area: Oncology Product Name: ABI-009

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Foundation Medicine

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration May 09, 2022

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Based on data from the AMPECT trial with FYARRO and following discussions with the FDA about other emerging data with FYARRO, Aadi has initiated PRECISION 1, a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors.


Lead Product(s): Nab-Sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 08, 2022

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FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).


Lead Product(s): Nab-Sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2022

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nab-Sirolimus (ABI-009), an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors.


Lead Product(s): Nab-Sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2021

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The combined, publicly traded company will focus on the advancement, expansion and commercialization of Aadi’s clinical stage pipeline, including Aadi’s lead program for its nanoparticle albumin-bound mTOR inhibitor, FYARRO™, an mTOR inhibitor bound to human albumin.


Lead Product(s): Nab-sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Aerpio Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger August 26, 2021

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Proceeds from the PIPE financing are expected to be used for the commercialization of FYARRO in advanced malignant PEComa, a planned tumor-agnostic registrational trial in solid tumors harboring inactivating alterations in the mTOR pathway genes TSC1 and TSC2.


Lead Product(s): Nab-sirolimus

Therapeutic Area: Oncology Product Name: Fyarro

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Acuta Capital Partners

Deal Size: $155.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement August 26, 2021

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